Veru Shares Jump Over 40% Despite FDA Staff Raises Uncertainties Over Its COVID-19 Therapy

Vandana Singh
1 min read
0
In this article:

  • Veru Inc (NASDAQ: VERU) is set to face an FDA Advisory Committee meeting on Wednesday regarding its emergency use authorization (EUA) application for the oral COVID-19 therapy sabizabulin.

  • At first, the meeting was supposed to happen on October 6, and then it was pushed to November 9.

  • The company's shares are up after the FDA published the briefing documents on sabizabulin ahead of its Pulmonary-Allergy Drugs Advisory Committee meeting.

  • The FDA review team has identified multiple uncertainties related to the data from Study 902 that the company used for its EUA application for sabizabulin.

  • While the trial met the primary goal, the reviewers note that the VERU-111 program is quite small compared to other therapeutic programs for patients hospitalized with COVID-19.

  • The issues such as high placebo mortality rate as a whole found "in a small trial which is more vulnerable to imbalances raise questions about the results," the FDA reviewers wrote.

  • "We ask the AC panel to consider these uncertainties together and how they affect the interpretation of the mortality data," they added, acknowledging that "none of the issues alone invalidate the mortality benefit observed in Study 902."

  • Price Action: VERU shares are up 40.10% at $14.49 on the last check Monday.

See more from Benzinga

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Advertisement

Recommended Stories